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94 WUNSCH AND MATUSCHKA and IPL treatment.9 Photon emitters, such as lasers or LEDs, have proven to be effective light sources for PBM during re- cent decades, thereby demonstrating that it is not the technical type of light source but the treatment parameters such as wavelength, irradiance, and fluence that are likely to be ac- countable for the effects.10 However, laser and LED light sources may offer some disadvantages because of their dot- shaped (punctiform) emission characteristics and narrow spectral bandwidths. Because the action spectra for tissue regeneration and repair consist of more than one wave- length,7,11 it might be favorable to apply a polychromatic spectrum covering a broader spectral region for skin rejuve- nation and skin repair. We investigated the safety and efficacy of a novel non-thermal, non-ablative, atraumatic, polychro- matic low-level light treatment modality with a focus on pleasant skin feeling, improved skin appearance, intradermal collagen increase, and the visible reduction of fine lines and wrinkles in a prospective, randomized, controlled trial that consisted of 136 volunteers. Materials and Methods Study population and design We conducted a randomized, controlled clinical trial be- tween January 2012 and December 2012. Table 1 summarizes the baseline (t0) characteristics of the subject groups. The subjects were between 27 and 79 years of age. Inclu- sion criteria were the capacity to independently position oneself to use the device, the capacity to understand the treatment, a signed declaration of consent, and interest in continuous participation. The exclusion criteria were physi- cal and psychological disease casting doubt on the capacity to consent, preliminary treatment with red light within the 6 months prior to the beginning of the study, recent invasive cosmetic procedures such as Botox during the 12 months prior to the beginning of the study, acute or prior skin cancer, acute skin disease requiring dermatological treatment, existing or planned pregnancy, lactation, history of photo- sensitivity or recent use of photosensitizing medication, epilepsy, and the tendency to faint. All of the participants gave written informed consent for this study, which was approved by the Ethics Committee of the Medical Associa- tion (Landesa ̈ rztekammer) Baden-Wu ̈ rttemberg, Stuttgart, Germany. The investigation was conducted in accordance with the Declaration of Helsinki (DoH/Oct2008). After the declaration of informed consent following examination of the inclusion and exclusion criteria, each participant was assigned to one of four groups using a computerized ran- domization process. Group 5 was mainly recruited from employees of the JK company without randomization, and served as the control. Groups 1–4 were treated twice a week with 30 treatments in total, starting in January 2012. To minimize the influence of seasonal changes, the time interval for data acquisition at the baseline, t15, t30, and follow-up examinations was restricted to 1 month. The data acquisition at baseline was completed in February 2012, and all of the volunteers finished treatment 30 (t30) in June 2012. The control group did not receive any treatment, as the therapy cannot be blinded, and a sham light source without any effect most likely does not exist. The control group volunteers participated in the clinical measurements only, and the acquisition of subjective parameters such as skin feeling and skin complexion was not conducted. Because of the similar spectral lamp characteristics for groups 1 and 2 and groups 3 and 4, groups 1 and 2 were combined for evaluation as the ‘‘mid-pressure lamp group’’ [energizing light technology (ELT)], and groups 3 and 4 were evaluated together as the ‘‘low-pressure lamp group’’ [red light tech- nology (RLT)] to obtain larger group sizes and, therefore, higher statistical power. Nevertheless, the subdivision into groups 1–4 allowed us to compare outcomes based on dif- ferent treatment parameters, such as spectral distribution, irradiance, and fluence. A questionnaire concerning the tol- erability of the application was filled in after each treatment (t1–t30). Digital photographs and clinical measurements were taken, and subjective questionnaires were used to as- sess complexion and skin feeling at the baseline (t0) and after 15 (t15) and 30 treatments (t30). The follow-up acquisition of Table 1. Baseline (t0) Characteristics of the Subject Groups RLT (n=57) Female 49/86.0% ELT (n=48) 34/70.8% 14/29.2% 48.6 – 9.8 73.4 – 13.7 4.87 – 2.02 5.24 – 2.18 14.84 – 4.04 18.96 – 3.54 17/35.4% 11/22.9% 11/22.9% 9/18.8% Controls (n=23) 15/65.2% 8/34.8% 44.4 – 10.2 73.7 – 13.4 11.79 – 2.17 23.22 – 7.36 5/21.7% 6/26.1% 9/39.1% 3/13.0% Sex Male 8/14.0% Agea Weighta Skin complexion (subjective)b Skin feeling (subjective)b Skin roughness (Ra)b Collagen intensity scorec Expert wrinkle assessmentd No/shallow or fine wrinkles Moderate wrinkles Prominent or deep wrinkles No majority vote possible 46.2 – 9.0 72.9 – 15.22 4.54 – 1.92 5.33 – 2.04 15.29 – 4.20 20.40 – 6.55 14/24.6% 20/35.1% 13/22.8% 10/17.5% aValues represent means – SD at t0. bValues represent means – SD at t0; small numbers indicate good values. cValues represent means – SD at t0; large numbers indicate good values. dMajority vote of three blinded expert reviewers, based on the Modified Fitzpatrick Wrinkle Scale. RLT, red light technology; ELT, energizing light technology.PDF Image | Trial to Determine the Efficacy of Red Near-Infrared Light Treatment
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